
Stand Out in Your Field with Specialized Training
Driven by the expanding biopharmaceutical market but also relevant to small molecule drug product and API manufacturing, aseptic processing is undergoing a technology evolution driven by the new EC GMP Guide Annex 1. Manufacturers which deliver drugs to Europe, must comply with this new regulatory requirement, which impacts all stakeholders. Additionally, suppliers must consider Annex 1 when supplying and installing new equipment or building new production facilities.
To meet the challenges of the new Annex 1 guidance while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 4-day interactive training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. This training provides hands-on opportunities to interact with equipment in a facility built for training pharmaceutical industry workers. During the training sessions, attendees will have the opportunity to conduct aseptic processing steps as well as ATMP manufacturing exercises in the clean rooms at the EASE facility including preparation and aseptic manipulation inside biological safety cabinets.
Overview of EASE Facility
Strasbourg, France
Days 1 and 2 of the hands-on training event will focus on aseptic processing & Annex 1. Under the constraints of a Grade B clean room, attendees will work closely with fill and finish aseptic lines where instructors explain the various options for setting up the equipment and loading stoppers.
Finally, a follow-up virtual meeting will be conducted to allow additional Q&A with the instructors.
Note: To maximize the time in the clean room area, several modules of training material will be sent prior to the event for pre-read and Q&A time will be allotted during the instructional sessions.
Upon completing days 1 and 2 of this event, you will be able to:
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
Days 3 and 4 of the hands-on training event will be focused on Advanced Therapy Medicinal Products (ATMPs) manufacturing. Course material is focused on the commercial manufacture of ATMP drug products in manufacturing facilities. Training will focus the proper implementation of facilities and equipment to ensure that quality products are consistently manufactured, as well as addressing potential manufacturing issues. Material will be drawn from the ISPE ATMPs Autologous Cell Therapy Good Practice Guide (GPG). Course material establishes guiding principles from the GPG that should be considered in the implementation of ATMP manufacturing processes. The training will be presented from the perspective of an allogeneic or autologous cellular therapy or gene-modified cellular therapy. Attendees in this course will have the opportunity to participate in hands-on exercises inside a clean room where they will learn how to conduct aseptic operations under a biological safety cabinet (BSC). Additionally, participants will be provided an overview of upstream and downstream processes.
To maximize the time in the clean room area, several modules of training material will be sent prior to the event for pre-read and Q&A time will be allotted during the instructional sessions.
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
Early Registration | Regular Registration | |
---|---|---|
Member | $4,700.00 | $5,000.00 |
Non Member | $5,000.00 | $5,600.00 |
Government | $1,600.00 | $1,600.00 |
Student | $1,000.00 | $1,000.00 |
EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU